Moderna Inc., a Cambridge, MA biotech company, announced on Sunday that they received additional funding from the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) in the amount of $472 million.
What We Know:
- The additional funding will support the expansion of the Phase 3 study of their COVID-19 vaccine candidate (mRNA-1273), which began Monday in Savannah, GA in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and BARDA. Phase 3 is a wide-spread human trial in order to test the vaccine’s safety and efficacy. Moderna’s study will be tested at 89 U.S. sites and, due to additional funding, will be able to include approximately 30,000 healthy participants. They are the first in the United States to begin human trails for a Coronavirus vaccine.
- Dr. Anthony Fauci, the director of NIAID, claims that early results from the Phase 3 study may be available in November or December if the trial enrolls quickly in places with high case loads. The study will use public health data to identify high-incidence areas and epicenters so sites near the locations can be prioritized for enrollment. Fauci says that, “The trail is designed to show the vaccine is at least 60% effective in preventing COVID-19”.
- In April, the company received $483 million from BARDA while the vaccine was still in the early stages of trials by the U.S. National Institutes of Health. Including the recent addition, this puts the company’s total BARDA funding at $955 million.
- Moderna and NIAID collaborated in the development of the vaccine and the conduct of the Phase 1 study. On July 10, the company surpassed Phase 2 of the study in collaboration with BARDA – which included 600 participants. According to BARDA, “The vaccine candidate received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in May”.
- According to CEO, Stéphane Bancel, the company is encouraged that their vaccine may help address the current pandemic and prevent future outbreaks of the disease. Because the vaccine uses a synthetic RNA to fight the virus, it may be able to immunize the body against the virus and has potential for faster development and manufacturing. The company claims they are on track for a 2021 production of about 500 million to 1 billion doses per year.
- On Monday, the U.S. Department of Health and Human Services expanded manufacturing capacity for the possible vaccine by reserving the Center for Innovation in Advanced Development and Manufacturing (CIADM) at Texas A&M University. The CIADM is a public-private partnership between BARDA and Texas A&M University System, with manufacturing subcontracted by FUJIFILM Diosynth Biotechnologies. The task values at about $265 million and would reserve the manufacturing expansion through December of 2021 for U.S. government partners developing vaccines under Operation Warp Speed, which was set out by President Donald Trump.
- As the possibility of a preventative vaccine increases, the stock market has been more engaged, with the Moderna stock spiking when the Phase 1 results showed promise. Since then, it has risen and fallen periodically. However, it brings into question the possibility of President Trump’s reelection. Some analysts are claiming that if the vaccine were to be approved, manufactured, or even show some sort of promise by the November election, it may increase Donald Trump’s chances of winning. Between the stock market reengaging and the possibility of control over the virus, it could be that this vaccine is the boost Trump needs.
As the trial continues, scientists are hopeful to find a preventative measure to the virus. To sign up to be apart of the trial at your local site, visit here.
